Sandoz biosimilar trial hailed as ‘landmark’

Clinical data for Sandoz’s biosimilar of Amgen/Pfizer’s Enbrel (etanercept) was based on a “landmark” trial design in psoriasis, where more than 500 patients switched between the originator and the near-copy.

Data from the EGALITY trial showed the Novartis unit’s biosimilar, filed in the US and EU, met primary endpoint of Psoriasis Area and Severity Index (PASI) 75 response, after 12 weeks.

The study compared safety and efficacy of its biosimilar etanercept candidate with Enbrel in patients with moderate-to-severe chronic plaque-type psoriasis.

Biosimilars are cheaper near-copies of biologic drugs – as they are proteins their amino acid sequence must be identical, but they may differ in other ways, such as where sugar molecules are attached. To make things more complicated, the originator product can also vary over time.

Regulators in the EU and US allow biosimilars to have a truncated approval process but nevertheless they are still expensive to develop compared with small molecule generics.

Professor Diamant Thaci, of the Comprehensive Center for Inflammation Medicine, University Medical School Schleswig-Holstein, Lubeck, said: “The EGALITY study is a landmark in clinical trial design. Data has been collected from over 500 patients in one year with multiple treatment switches where a patient receives either the biosimilar etanercept candidate or the originator product on a number of alternate occasions.”

“Data from this study, in addition to analytical, functional and pre-clinical studies, provides confidence in the comprehensive data package that is the basis for biosimilar medicine approval and use by healthcare practitioners.”

Data supporting switching from originator to biosimilar is key, as it gives doctors confidence that the entire patient population can be prescribed the biosimilar, not just those who have just begun treatment.

Sandoz’s biosimilar was accepted by the EMA and FDA for regulatory review in the second half of 2015.

It is seeking approval for all indications included in the label of the originator product, which is used to treat various inflammatory conditions, including rheumatoid arthritis and psoriasis.

The company plans five biosimilars in oncology and immunology by 2020.

Biogen has already launched an Enbrel biosimilar in Europe. The original product netted Amgen just over $5 billion for the full year in 2015, up 14% from the year before, and is one of a group of key biologic drugs that are to come under pressure from biosimilar competitors in the near future.

IMS estimates that biosimilars could save health systems in the US and EU up to $110 billion by the year 2020.